G18 - Breakthrough pain in patients with head and neck cancer: efficacy and safety of buccal fentanyl citrate

Abstract

Background: More than 50% of patients with cancer experience pain, which is often of moderate-to-severe intensity. In particular, the highest prevalence of pain is observed in head-neck tumours (70%). In patients with advanced disease, management of pain remains a particular challenge. The breakthrough cancer pain (BTcP) is a transient pain, a temporary exacerbation with variable frequency (1-6 times a day), which occurs in patients with chronic pain normally well controlled by basic analgesic therapy administered at fixed times (therapy around-the-clock).Material (patients) and methods: from January 2012 to March 2015 we collected data from 50 patients with histological diagnosis of squamous cell carcinoma of the head and neck treated for symptomatic BTcP with fentanyl citrate buccal tablets. Basic pain was treated with oxycodone/naloxone at doses from 10 mg bid to 80 mg bid. The patients were evaluated for BTcP onset and any associated precipitating was considered. Treatment for BTcP with fentanyl citrate buccal tablets has been proposed at a starting dose of 100 micrograms increased up to 800 micrograms and repeatable every 4 hours. During the observation period all patients were assessed weekly by clinical examination and pain was valued through NRS.Results: basic chronic pain was well controlled with oxycodone/naloxone demonstrated by a reduction in NRS (average score from 7 to 2). Of the 50 patients with carcinoma of the head and neck, 22 patients had BTcP episodes repeated daily related to swallowing and 14 patients had episodes triggered by medication of external lesions; none of these episodes was attributable to the end of basic opioid dose. The maximum number of daily episodes was 5 for the BTcP triggered by swallowing and 3 for the one triggered by medication (average NRS was 8). The average effective dose of fentanyl buccal tablets was 400 micrograms bid and all patients reported disappearance of BTcP episodes. About side effects mainly observed, nausea occurred in 4% of cases and only 2% presented pain and bleeding where the tablet was applied.Conclusions: over 70% of the patients analyzed in our study suffered of repeated episodes of BTcP reflecting literature data. NRS scale reduction for chronic pain and BTcP episodes disappearance demonstrated efficacy of the therapies. Safety was demonstrated by the minimal side effects so that switching to another formulation of rapid-onset opioids wasn't necessary. Background: More than 50% of patients with cancer experience pain, which is often of moderate-to-severe intensity. In particular, the highest prevalence of pain is observed in head-neck tumours (70%). In patients with advanced disease, management of pain remains a particular challenge. The breakthrough cancer pain (BTcP) is a transient pain, a temporary exacerbation with variable frequency (1-6 times a day), which occurs in patients with chronic pain normally well controlled by basic analgesic therapy administered at fixed times (therapy around-the-clock). Material (patients) and methods: from January 2012 to March 2015 we collected data from 50 patients with histological diagnosis of squamous cell carcinoma of the head and neck treated for symptomatic BTcP with fentanyl citrate buccal tablets. Basic pain was treated with oxycodone/naloxone at doses from 10 mg bid to 80 mg bid. The patients were evaluated for BTcP onset and any associated precipitating was considered. Treatment for BTcP with fentanyl citrate buccal tablets has been proposed at a starting dose of 100 micrograms increased up to 800 micrograms and repeatable every 4 hours. During the observation period all patients were assessed weekly by clinical examination and pain was valued through NRS. Results: basic chronic pain was well controlled with oxycodone/naloxone demonstrated by a reduction in NRS (average score from 7 to 2). Of the 50 patients with carcinoma of the head and neck, 22 patients had BTcP episodes repeated daily related to swallowing and 14 patients had episodes triggered by medication of external lesions; none of these episodes was attributable to the end of basic opioid dose. The maximum number of daily episodes was 5 for the BTcP triggered by swallowing and 3 for the one triggered by medication (average NRS was 8). The average effective dose of fentanyl buccal tablets was 400 micrograms bid and all patients reported disappearance of BTcP episodes. About side effects mainly observed, nausea occurred in 4% of cases and only 2% presented pain and bleeding where the tablet was applied. Conclusions: over 70% of the patients analyzed in our study suffered of repeated episodes of BTcP reflecting literature data. NRS scale reduction for chronic pain and BTcP episodes disappearance demonstrated efficacy of the therapies. Safety was demonstrated by the minimal side effects so that switching to another formulation of rapid-onset opioids wasn't necessary.